Regulatory Perspectives


  • Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials

    Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials

    Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…
    Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18

  • Innovation in the 510(k) Space: A Case for Incrementalism

    Innovation in the 510(k) Space: A Case for Incrementalism

    Although the term “innovative technology” often evokes images of a breakthrough, radical discovery, or inventive cure-all, the certainty associated with incremental improvements to established, higher-risk technologies such as implantable…
    Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18

  • Design | Research & Development
    The Hidden Costs of Clinical Trial Agreement Negotiations

    The Hidden Costs of Clinical Trial Agreement Negotiations

    Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…
    Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18

  • Software & Quality
    Medical Device Quality: Why Software Is More Challenging Than Hardware

    Medical Device Quality: Why Software Is More Challenging Than Hardware

    The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,&r…
    Dan Goldstein, Manager, Quality Assurance, Musculoskeletal Clinical Regulatory Advisors 03.21.18

  • The Impact of U.S. Regulation on Medical Device Innovation

    The Impact of U.S. Regulation on Medical Device Innovation

    Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. During World War II, antibiotics were scarce and chronic osteomyelitis and bone deficiencies such as non-unions and deformities were common.…
    Patricia Kontoudis, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 02.12.18

  • Comparing CGMP Pharma vs. Device:  Subpart A—General Provisions (Part II)

    Comparing CGMP Pharma vs. Device: Subpart A—General Provisions (Part II)

    Despite maintaining a somewhat close professional relationship, the pharmaceutical and medical device industries are complete strangers in many ways. Between product development timelines, innovation, and outsourcing, the two sides lead mostly separa…
    James A. Dunning, Owner, QPC Services LLC 10.02.17

  • Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite…
    James A. Dunning, Owner, QPC Services LLC 08.15.17

  • Current Good Manufacturing Practices: Pharma vs. Device

    Current Good Manufacturing Practices: Pharma vs. Device

    After years of working in and consulting for pharmaceutical and medical device companies on quality and regulatory matters, I am still somewhat surprised by the difficulty both industries have in understanding the other’s Current Good Manufactu…
    James A. Dunning, Owner, QPC Services LLC 05.19.17

  • Risk Management Lessons Beyond ISO 14971

    Risk Management Lessons Beyond ISO 14971

    Risk management used to be simple. Much simpler than it is now, if my memory serves me correctly. I’m not dreaming, am I? Risk management was simpler back in the day, wasn’t it? Alas, maybe it was never simple, and I’ve just forg…
    James A. Dunning, Owner, QPC Services, LLC 03.22.17

  • Software & Quality
    The Form, Fit, and Function of the Quality Role

    The Form, Fit, and Function of the Quality Role

    I think a lot about role of quality in companies today. This may seem odd, given my vast experience in quality and regulatory compliance, but there are still situations that are new to me. I have not, nor will I ever, “see it all.” Qualit…
    James A. Dunning, Owner, QPC Services, LLC 02.23.17

  • Seven Year-End Reflections of a Regulatory Professional

    Seven Year-End Reflections of a Regulatory Professional

    It’s hard to believe that 2016 is almost over. For me, the months of November and December go by faster than any other 60-day period in the year. With the push to get things done before year’s end and the flurry of seasonal events, it can…
    James A. Dunning, CEO, QPC Services 11.22.16

  • New Draft Guidance Released on 510(k) Submissions

    New Draft Guidance Released on 510(k) Submissions

    For much of my career, I have relied on the trusty K97 Memo, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” released in January 1997. This guidance has served the U.S. Food and Drug Administration (FDA) and overall…
    James A. Dunning, CEO, QPC Services 09.20.16

  • The Regulation of Advanced Manufacturing

    The Regulation of Advanced Manufacturing

    I grew up in Roseville, Mich., at a time when manufacturing was central to the local economy. Back then, heavy industrial manufacturing was king. But over the years, the art of mass production has changed significantly. From automation and robotics t…
    James A. Dunning, QPC Services 08.09.16

  • The Value of Design Controls

    The Value of Design Controls

    I’ve never met anyone who does not readily acknowledge the benefits of design controls (21 CFR Part 820.30). Considered essential for medical device design firms, design controls are invaluable, as they help companies maintain regulatory compli…
    James A. Dunning, QPC Services 05.23.16

  • Crack the Clinical Evaluation Report Enigma

    The clinical evaluation report (CER) increasingly has become a key topic in the medical device regulatory world, particularly given the scandals including Poly Implant Prostheses’ (PIP) use of cheaper, industrial-grade silicone in breast implan…
    Chris Rule, Contributing Writer 11.17.15

  • Postmarket Obligations for U.S. Companies Marketing Medical Devices in Europe

    Gaining CE mark approval in Europe for a medical device and in-vitro diagnostic (IVD) device is a complex process. Many non-European manufacturers are unaware of individual country requirements and that systems for vigilance and postmarket surveillan…
    09.15.15

  • The New Role of Regulatory Affairs in Medical Device Manufacturing

    Call it a new paradigm. Call it a sea change. Or, if you prefer, call it downright frustrating. Whatever label you give to today’s medical device environment, the current and future reality is that the regulatory elements of medical technology…
    Kellen Hills, Orchid Orthopedic Solutions 12.01.14

  • Kellen Hills is the senior regulatory consultant for Orchid Orthopedic Solutions. In addition to d

    Kellen Hills is the senior regulatory consultant for Orchid Orthopedic Solutions. In addition to designing and manufacturing implants and instruments for the orthopedic, dental and cardiovascular markets, Orchid provides regulatory expertise, docum…
    12.01.14

  • Katherine Ulman has been with Dow Corning Corp. for more than 38 years and currently is the global

    Katherine Ulman has been with Dow Corning Corp. for more than 38 years and currently is the global regulatory compliance manager for the company’s Healthcare unit. Ulman is a member of the American Chemical Society, the American Association o…
    09.16.14

  • Proposed Changes to EU Medical Device Directive Make Little Progress

    Proposed Changes to EU Medical Device Directive Make Little Progress

    EDMA maintains that it strongly supports a five-year transition period for IVDs.
    Ranica Arrowsmith, Associate Editor 04.02.14